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Creation of a Cohort for the Quantitation and Characterization of Circulating Viral RNAs as a New Biomarker of Hepatitis B Functional Cure. (CirB-RNA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03825458
Recruitment Status : Recruiting
First Posted : January 31, 2019
Last Update Posted : December 23, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:
The " CirB-RNA " cohort aims to create a biological collection associated with clinical and biological data from patients with hepatitis B infection. This project is part of a much larger program that aims to characterize and quantify circulating viral RNAs as a possible new biomarker of hepatitis B functional cure.

Condition or disease Intervention/treatment
Hepatitis B Other: Blood sampling

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Study Type : Observational
Estimated Enrollment : 3500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Creation of a Cohort for the Quantitation and Characterization of Circulating Viral RNAs as a New Biomarker of Hepatitis B Functional Cure.
Actual Study Start Date : February 25, 2019
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : October 31, 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Blood sampling
    Blood sampling at each clinical follow-up visit.


Primary Outcome Measures :
  1. Number of plot samples collected [ Time Frame: maximum 46 months ]

    The aim of this study is the constitution of a cohort with biological collection associated with clinical and biological data Data and samples will be collected at each follow-up visit until end of project (longitudinal study).

    This cohort is the first step of a research program and will be use in further study which are part of this research program. All studies of this research program aim to improve knowledge about hepatitis B, develop and validate a new biomarker of hepatitis B cure.



Biospecimen Retention:   Samples Without DNA
Plasma EDTA and serum


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with hepatitis B infection (acute or chronic) or presenting with HBsAg loss (with/without anti-HBs seroconversion).
Criteria

Inclusion Criteria:

  • Adults patients with acute or chronic hepatitis B or presenting with HBsAg loss (with/without HBs seroconversion). (Co-infected patients with HDV and/or HCV and/or HIV are eligible)
  • Patients requiring blood sampling for medical care at the time of the medical appointment.
  • Informed patients who do not refuse to participate.
  • Persons not affiliated to a social security scheme and persons receiving medical assistance from the state may be asked to participate in the study

Exclusion Criteria:

  • Patients participating at the time of the inclusion to an interventional trial evaluating a drug likely to interfere with this study.
  • Persons deprived of their liberty by a judicial or administrative decision
  • Adults who are subject to a legal protection measure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03825458


Contacts
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Contact: Fabien ZOULIM, Pr 04 26 10 93 55 ext +33 fabien.zoulim@chu-lyon.fr
Contact: Massimo LEVERO, Pr 04 72 68 19 79 ext +33 massimo.levrero@inserm.fr

Locations
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France
Hepatology department - Groupement Hospitalier Nord - Hôpital de la Croix-Rousse Recruiting
Lyon, France, 69004
Contact: Fabien ZOULIM, Pr    04 26 10 93 55 ext +33    fabien.zoulim@chu-lyon.fr   
Hôpital de la Croix-Rousse - Service de maladies infectieuses et tropicales Recruiting
Lyon, France, 69317
Contact: Patrick MIAILHES, MD, PhD    04 26 73 26 58 ext +33    patrick.miailhes@chu-lyon.fr   
Principal Investigator: Patrick MIAILHES, MD, PhD         
Italy
Gastroenterology and Hepatology department - • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Not yet recruiting
Milan, Italy, 20122
Contact: Pietro LAMPERTICO, Pr    0255035432 ext +39    pietro.lampertico@unimi.it   
Gastroenterology and Hepatology department - • Università degli Studi di Palermo Not yet recruiting
Palermo, Italy, 90133
Contact: Antonio CRAXI, Pr       antonio.craxi@unipa.it   
Infectious diseases and hepatology unit - Azienda Ospedaliero Not yet recruiting
Parma, Italy, 43126
Contact: Carlo FERRARI, Pr    0521702762 ext +39    cferrari00@gmail.com   
Sponsors and Collaborators
Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03825458    
Other Study ID Numbers: 69HCL18_0436
2018-A02558-47 ( Other Identifier: ID-RCB )
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: December 23, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections